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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT100 OPERATING ROOM TABLE
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IMRIS - DEERFIELD IMAGING, INC. IMRIS ORT100 OPERATING ROOM TABLE Back to Search Results
Model Number ORT100
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 07/25/2017
Event Type  malfunction  
Manufacturer Narrative
The ort100 table rotational locking mechanism was removed and replaced with the most recent design to resolve the issue.Table was tested to verify proper function.Internal capa issued.
 
Event Description
Scheduled or table rotational lock repair and upgrade as a result of an observation during preventive maintenance.No patient involvement.
 
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Brand Name
IMRIS ORT100 OPERATING ROOM TABLE
Type of Device
OPERATING ROOM TABLE
Manufacturer (Section D)
IMRIS - DEERFIELD IMAGING, INC.
5101 shady oak road
minnetonka MN 55343 4100
Manufacturer (Section G)
IMRIS - DEERFIELD IMAGING, INC.
5101 shady oak road
minnetonka MN 55343 4100
Manufacturer Contact
todd sperling
5101 shady oak road
minnetonka, MN 55343-4100
7632036344
MDR Report Key7249572
MDR Text Key99825633
Report Number3010326005-2018-00016
Device Sequence Number1
Product Code KXJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Remedial Action Inspection
Type of Report Initial
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model NumberORT100
Device Catalogue Number110470-000
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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